UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function : double blind, placebo-controlled study
Title of the study (Brief title)	The beneficial effect of a functional food containing Lactobacillus on human gastrointestinal function
Region	Japan

Condition
Condition	Individuals with a tendency for constipation
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to investigate the efficacy of the intake of the functional food on individuals with constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	defecation frequency, stool output
Key secondary outcomes	defecation days, fecal condition

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	intake of a test food containing with lactobacillus for 2 consecutive weeks
Interventions/Control_2	intake of a placebo for 2 consecutive weeks
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Males and females from 20 to 64 years of age (2) Subjects with a tendency for constipation at three to five times of defecation per week
Key exclusion criteria	(1) Subjects who routinely takes foods or medicines containing of Lactobacillus (2) Subjects who routinely takes foods or medicines containing of Bacillus subtilis var. natto (3) Subjects who routinely takes foods or medicines affecting the test result (4) Subjects having diseases affecting bowel movement or a history of these diseases (5) Subjects having possibilities for emerging allergy related to the study (6) Subjects who has asthma or the possibility of asthma (7) Subjects who is employed on a pre-dawn shift or on night duty more than 2 times (8) Subjects who is planned to go overseas (9) Subjects who has treatment or a history of serious disease (10) Subjects who has treatment of disease (11) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on screening test (12) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (13) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (14) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (15) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	100

Research contact person
Name of lead principal investigator	Takehisa Kumagai
Organization	KAMEDA SEIKA CO., LTD.
Division name	RICE RESEARCH INSTITUTE
Address	3-1-1 Kameda Kogyo Danchi, Konan-ku, Niigata City, Niigata
TEL	025-382-8879
Email	t_kumagai@sk.kameda.co.jp

Public contact
Name of contact person	Shingo Yamamichi
Organization	TTC Co.,Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	KAMEDA SEIKA CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 11 Day
Anticipated trial start date	2017 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 19 Day
Last modified on	2017 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031399